| - | - | - |
|---|---|---|
| Product Group | : | Parasiticides |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | Ivermectin, Clorsulon |
| Target Type | : | Cattle |
| Package Form | : | 50-100 ml |
For Animal Use Only
For Animal Use Only
Solution for Injection
Veterinary Endectocide and Faciolacide
Pharmacodynamic Properties
Ivermectin is a derivative of macrocyclic lactone and acts by inhibiting nerve conduction. In parasites, glutamate binds with high selectivity to gated chloride ion channels, hence permeability of cell membranes to chloride ions increases, hyperpolarization of nerve or muscle cells, paralysis and eventually death. This class of compounds interacts with ligand-gated chloride channels, the gating channels of neurotransmitters such as GABA. Their safety in mammals is due to the absence of glutamate-gated chloride channels in mammalian cells. Macrocyclic lactones show low affinity for ligand-gated chloride channels in mammals and do not readily cross the blood brain barrier.
Clorsulon is a sulfonamide. It enters the bloodstream rapidly. In adult F. hepatica, it acts lethally by inhibiting enzymes involved in the glycolytic pathway, the main source of energy.
Pharmacokinetics Properties
After subcutaneous administration at the therapeutic dose, ivermectin reaches peak plasma concentration (Cmax: 65.80 ng/ml) after 1-2 days and chlorsulone (Cmax: 2.58 μg/ml) after approximately 8 hours. Half-lives are approximately 3.79 days for ivermectin and 3.58 days for clorsulon.
Only 2% of ivermectin is excreted in the urine, the main route of excretion is the gaita. After administration, it is highest in the liver and adipose tissue and lowest in the brain.
The residual antiparasitic effect in cattle is due to its long half-life and 90% binding to proteins.
USE OF AREA / INDICATIONS
It is used for the treatment of the following internal and external parasites in cattle.
- Gastrointestinal nematodes:
Ostertagia ostertagi (adult; L3 larva; L4 larva, including hipobiosis),
Ostertagia lyrata (adult and L4 larva),
Haemonchus placei (adult; L3 and L4 larva),
Macistocirrus digitatus (adult)
Trichostrongylus spp. (adult, L4 larva),
Cooperia spp. (adult and L4 larva),
Oesophagostomum radiatum (adult; L3 and L4 larva),
Nematodirus spp. (adult),
Bunostomum phlebotomum (adult; larva L3 adult L4),
Strongyloides papillosus (adult),
Trichuris spp.(adult),
Toxocara vitulorum (adult, L3 and L4 larva)
- Lung nematodes (Adult and 4. Level larva):
Dictyocaulus viviparus
- Subcutaneous nematodes:
Parafilaria Bovicola (adult)
- Eye nematode
Thelazia spp. (adult)
-Nocra factors (larval stage):
Hypoderma bovis,
Hypoderma lineatum
Dermatobia hominis
Chrysomya bezziana
-Scabies:
Psoroptes ovis,
Sarcoptes scabiei var. bovis
-Lice:
Linognathus vituli,
Haematopinus eurysternus,
Solenopotes capillatus
-Tick:
Ornithodorus savignyi
Boophilus microplus
-Liver trematode:
Fasciola hepatica (adult)
Fasciola gigantica (adult)
Ivermectin can be used to control Damalinia bovis and Chorioptes bovis, but complete elimination may not be possible.
Use of this product at the recommended dose can prevent re-infection for 14 days for Haemonchus placei, Cooperia oncophora, Cooperia pectinata and Trichostrongylus axei, 21 days for Ostertagia ostertagi and Oesophagostomum radiatum and 28 days for Dictyocaulus viviparus.
The timing of treatment may vary according to epidemiological factors and the characteristics of the enterprise. The application program should be evaluated by the veterinarian.
USAGE AND DOSAGE
It is administered as a single dose.
The body weight of the animals should be measured as accurately as possible for correct dosing. The accuracy of the dosing device should be checked.
If herd treatment is to be applied, animals should be grouped appropriately to avoid over- or underdosing.
Application to wet or dirty animals is not recommended.
Dosage: 1 ml for 50 kg body weight (200 µg ivermectin and 2 mg Clorsulon per kg bodyweight)
Application: It is administered subcutaneously to the front or back of the shoulder area in accordance with the aseptic technique. Sterile, 1.4 x 15 mm (17G x ½ inch) niddle is adviced. Do not apply more than 10 ml to an injection site.
The application of the product may become difficult due to increased viscosity below 5 ºC. This problem is eliminated by heating the product to approximately 15 ºC. If it is used with other injectable products, different injection sites should be selected.
SPECIAL CLINICAL INFORMATION AND WARNING FOR TARGET SPECIES
The following practices should be avoided due to the risk of development of resistance and thus failure of treatment.
- The use of the same group of anthelmintics in very frequent and repeated doses within a certain period of time,
- Administering a dose that is less than the required dose due to miscalculation of body weight, misapplication of the product, or an application device that is out of calibration resulting in the wrong amount of product being administered.
Where resistance to anthelmintics is suspected, further investigations with appropriate tests (such as the fecal egg count reduction test (FECRT)) should be performed. If data indicate that resistance to a particular antihelminthic has developed, another product with a different pharmacological class and mode of action should be used.
Resistance to macrocyclic lactones, including ivermectin, has been reported in Teladorsagia in sheep, Ostertagia circumcinta in lambs, Ostertagia ostertagi and Cooperia in cattle. This product should therefore be used according to regional (farm or wider) epidemiological susceptibility data.
Avermectins may not be well tolerated in non-target species. Intolerance events resulting in death have been reported in dogs, especially Collies, Bobtails, Old English Sheepdogs and close or cross breeds, as well as in tortoises.
Do not combine with lung pinworm vaccines. If product is to be applied to vaccinated animals, it should be applied 28 days before or after vaccination.
Excretion of nematode eggs may continue for some time after treatment.
In cattle, to avoid secondary reactions caused by the death of Hypoderma larvae in the esophagus and spine, it is advisable to apply the product in the final stage of the nocturnal flies, before they reach these areas. The death of Hypoderma lineatum in the peri-esophageal tissue may cause salivation and tympania. Death of Hypoderma bovis in the spinal canal may cause paresis or paralysis.
Clean the vial before each use.
Use in Pregnancy and Lactation: This product may be used in pregnant cattle. For detailed information on use in lactation, see “Withdrawal Periods”. The product has no negative effect on fertility.
ADVERSE EFFECTS
Some animals may experience discomfort after subcutaneous application. In cattle this manifests as jumping and rolling. Behavior usually returns to normal 15 minutes after administration. Stiffening and swelling may occur at the injection site. These reactions are temporary and disappear within 1-4 weeks.
DRUG INTERACTIONS
Do not combine with lung pinworm vaccines. If the product is to be applied to vaccinated animals, it should be applied 28 days before or after vaccination.
Do not mix with other medicinal products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Clinical symptoms of ivermectin toxicity are ataxia and depression (at 20 times the recommended dose). There is no antidote. Symptomatic treatment should be applied in case of overdose. Lesions (necrosis, edema, fibrosis and inflammation) were observed at the injection site at 25 times the recommended dose.
WITHDRAWAL PERIODS
Meat: 66 days. Do not use in the cows from which milk is obtained for human consumption. Not for use in pregnant cows within 60 days before labor.
CONTRAINDICATIONS
Do not administer intravenously and intramuscularly. This product is only used in cattle. Not for use in other species, especially cats and dogs, due to possible serious side effects.
Not for use in animals known to be sensitive to its components.
GENERAL WARNINGS
Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Do not consume anything, including cigarettes, during the application of the product. Wash your hands after use. Since it causes irritation and pain at the injection site, take necessary precautions to prevent accidental injection. In case of self-injection, consult a doctor immediately along with the product and the package insert. Do not contact with the product. In case of accidental exposure, wash the area with plenty of water.
STORAGE CONDITIONS AND SHELF LIFE
Before and after opening, It should be stored under 25°C in the original package, without being frozen or placed in the refrigerator. Protect from sunlight. Shelf life is 2 years.
WARNINGS FOR DISPOSAL AND NON-TARGET SPECIES
HIGHLY TOXIC TO FISH AND AQUATIC LIFE. The product or used product containers should never be disposed of in or near water sources. The product is highly toxic to aquatic organisms and dung beetles. Cattle must not have direct access to ponds, streams or ditches within 14 days of treatment. Long-term effects on dung beetles cannot be neglected due to continuous or repeated use. Therefore, repeating treatments on a pasture during a seasonal period should only be done on the advice of a veterinarian. Used or leftover product should be disposed of in accordance with the relevant legislation.
COMMERCIAL PRESENTATION FORMS
Offered for sale in 50 ml and 100 ml amber colored glass vials in cardboard boxes..
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries. (VHR).
APPROVAL DATE OF LEAFLET: 14.03.2025
MARKETING AUTHORIZATION DATE AND NO: 25.02.2025-7
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
MANUFACTURER COMPANY
1- Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
2- FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
Made in Turkiye
